AIDS
Conditions
Interventions
placebo:Inocultate placebo of DNA vaccine 3 times and placebo of rTV vaccine once
DNA vaccine only:Inocultate high dosage DNA vaccine 3 times and placebo of rTV vaccine once
low dosage of DNA + rTV:Inocultate low dosage DNA vaccine 3 times and rTV vaccine once
high dosage of DNA + rTV:Inocultate high dosage DNA vaccine 3 times and rTV vaccine once
Sponsors
National Center for AIDS/STD Control and Prevention, China CDC
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Both male and female; 2. Age range 18-55 years old; 3. Admission intravenous blood sampling and sample storage in the 9 months after the first vaccination of vaccine; 4. Understand and agree with the content of informed consent; 5. Within the condition of low risk HIV prevalence: (1) No history of intravenous drug use; (2) No gonorrhea or syphilis in the last year; (3) No high risk sexual partners (e.g. IDU, HIV positive sexual partners) now and in the last year; (4) Have no sex with irregular sexual partner without condoms now and in the last year; 6. Would like to be tested for HIV and syphilis; 7. Before 2 weeks of the first vaccination and after 6 months of the last vaccination, would like to take effective contraception measures with sexual partner. Female subjects would like to have urine pregnancy test before each vaccination and at the follow-up visit.
Exclusion criteria
Exclusion criteria: 1.Have no mental health conditions for the clinical trial, as judged by psychologists; 2. Pregnancy or lactation, planning pregnancy during the clinical trial, or have close contact with people who are pregnant or lactating in the one month after vaccination of rTV vaccine; 3.Have listed diseases or medical history: (1) Have innate or Acquired Immune Deficiency Disease or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination; (2) Need treatment affecting immunization, e.g. use corticosteroids for more than 2 weeks or use immunosuppressives; e.g. alkylating, anti-metabolite or radiotherapy, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination; (3) Suffering from immunosuppressive diseases such as cancer, organ or stem cell transplants, non-agammaglobulinemia, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination; (4) Past or current suffering from eczema or atopic dermatitis; currently suffering from diseases that cause skin damage such as: burns, scald, chicken pox, impetigo, shingles, psoriasis, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination; (5) Past or current high blood pressure, heart disease, diabetes, thyroid disease, asthma, angioedema, spleen disease, mental illness, mental illness, epilepsy, etc.; (6) Diseases needing repeated injections or blood; (7) History of syncope after vaccination or history of allergies; (8) Currently suffering from acute infectious diseases and febrile diseases. 4. The following circumstances are: (1) Receipt of live attenuated vaccine within 2 months or other vaccine within 2 weeks of enrollment; (2) Receipt of immunoglobin or blood products within 4 months of screening; (3) Participation in another trial of a medicinal product, completed less than 30 days prior to enrollment; (4) Drug abuse, drug dependence, alcoholism, heavy smokers. 5. The following laboratory abnormalities, except for results of no clinical significance, as judged by researchers. (1) HIV antibody positive or suspicious, HIV nucleic acid test positive; (2) Anti-DNA antibodies or anti-nuclear antibody positive; (3) Hepatitis B surface antigen or hepatitis C antibody, syphilis rapid plasma regain test (RPR) positive; (4) Immunoglobulin G, A, M values are not within the normal range; (5) Lymphocyte phenotype analysis showed that cell value of CD3 +, CD4 +, CD8 +, CD8 + DR + / CD8 +, CD8 + CD38 + / CD8 + is not in the normal range; (6) Hemoglobin of females ==12.0*10^9/L; (8) Total lymphocyte count ==400*10^9/L; (10) Biochemical test: the value of serum glutamate pyruvate transaminase (ALT), glutamic-oxal(o)acetic transaminase (AST), creatine phosphokinase (CK) and its Isozyme (CK-MB), troponin (cTnI), fasting blood glucose, bilirubin (TBIL), nitrogen of carbamide (BUN), creatinine (Cr) etc is above the normal reference range; (11) Glucose of urine >=15mmol/L, proteinuria >=0.3g/L; 6. Not complying with study protocol or not obtaining informed consent because of medical, spiritual, social, occupational, and/or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Routine;urinalysis;detection of vaccinia virus hyperlipidemia;liver, and kidney function tests;HIV cellular immune response;CK-MB and troponin testing; | — |
Secondary
| Measure | Time frame |
|---|---|
| DNA/ANA antibody;HIV intracellular staining test;vaccinia virus antibody detection;HIV neutralizing antibody test;HIV antibody test;HIV nucleic acid test;HIV antigen-specific antibody test; | — |
Countries
China
Contacts
Public ContactTaisheng Li
Outcome results
None listed